Energy Homeostasis Under Treatment With Atypical Antipsychotics

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: olanzapine; Drug: Ziprasidone

• Registration Number: NCT00148564
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

The purpose of this study is to evaluate the effects of different atypical antipsychotics on weight changes, energy homeostasis, metabolism, energy intake as well as activity.

Patients with schizophrenia or schizoaffective disorders will be randomly assigned to be treated with ziprasidone or olanzapine for 24 weeks.

Primary outcome parameter are the weight changes after 24 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2007-03
• Study Completion: 2007-06
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-26
• Last Update Posted: 2008-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of schizophrenia or related disorders(DSM-IV)
• Indication for long-term treatment with antipsychotics
• BMI between 20 to 30
• Weight changes less than 3kg in the last 3 months before inclusion
• Informed consent

Exclusion Criteria

• Psychiatric comorbidity
• Depot antipsychotic in the last 2 months
• Antipsychotics in the last 2 weeks
• Treatment with olanzapine, clozapine or ziprasidone in teh last 3 months
• Treatment with drugs, that may lead to weight changes
• Significant endocrine, neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests
• Female subjects during pregnancy and breastfeeding
• Female subjects within childbearing years who were not using adequate birth control
• Patients who are judged by the investigator to be at serious suicide risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olanzapine	olanzapine	-
Zpirasidone	Ziprasidone	-

Primary Outcome Measures

Name	Time	Method
Primary outcome parameter are the weight changes after 24 weeks between olanzapine and ziprasidone treatment	during treatment

Secondary Outcome Measures

Name	Time	Method
Changes in energy homeostasis, food intake, metabolism	during and after treatment

Trial Locations

Locations (1)

Charité Universitaetsmedizin Berlin; Campus Charité Mitte; Dept. for Psychiatry and Psychotherapy; 🇩🇪 Berlin, Germany